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Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary and Secondary Ventral Hernia

Intervention: Placing the resorbable mesh (Procedure); Non-resorbable synthetic mesh. (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: University Hospital, Ghent

Official(s) and/or principal investigator(s):
Frederik Berrevoet, MD, PhD, Principal Investigator, Affiliation: Ghent University Hospital

Overall contact:
Frederik Berrevoet, MD, PhD, Email: Frederik.Berrevoet@ugent.be

Summary

Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result. The TIGRâ„¢ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen. The aim of this study is to compare TIGRâ„¢ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study). Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.

Clinical Details

Official title: Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Recurrence rate at 3 years post-surgery.

Secondary outcome:

Wound Morbidity 4 weeks post-surgery.

Pain and discomfort after 1 year post-surgery.

Pain and discomfort after 3 years post-surgery.

Recurrence rate by clinical examination 1 year post-surgery.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Primary and secondary ventral hernia

- less than 20 cm in length

- less than 6 cm in width

Exclusion Criteria:

Locations and Contacts

Frederik Berrevoet, MD, PhD, Email: Frederik.Berrevoet@ugent.be

Ghent University Hospital, Ghent 9000, Belgium; Recruiting
Frederik Berrevoet, MD, PhD, Phone: +32(0)93324892, Email: Frederik.Berrevoet@ugent.be
Frederik Berrevoet, MD, PhD, Principal Investigator

University Hospital Leuven, Leuven 3000, Belgium; Recruiting
Marc Miserez, MD, PhD, Email: Marc.miserez@uzleuven.be
Marc Miserez, MD, PhD, Principal Investigator

University of Copenhagen, Copenhagen DK-2400, Denmark; Recruiting
Lars Nannestad Jorgensen, MD, DrMSc, Email: Larsnjorgensen@hotmail.com
Lars Nannestad Jorgensen, MD, DrMSc, Principal Investigator

ul Jagalskiego, Wejherowo 84-200, Poland; Recruiting
Maciej Smietanski, MD, PhD, Email: smietanski@herniaweb.org
Maciej Smietanski, MD, PhD, Principal Investigator

Hospital de 12 Octobre, Madrid, Spain; Recruiting
Maria Teresa Butron Vila, MD
Maria Teresa Butron Vila, MD, Principal Investigator

Royal Infirmary of Edinburgh, Edinburgh EH16 4SA, United Kingdom; Recruiting
Andrew de Beaux, MD FRCS MBcChB, Email: Andrew.Debeaux@luht.scot.nhs.uk
Andrew de Beaux, MD FRCS MBChB, Principal Investigator

Additional Information

Starting date: February 2013
Last updated: December 4, 2014

Page last updated: August 23, 2015

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